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基准响应 (BMR) 在体内致变性终点的基准值
Paul A White1, Guangchao Chen2, Nikolai Chepelev1
1Environmental Health Science and Research Bureau, Environmental and Radiation Health Sciences Directorate, Health Canada, Ottawa, Canada.
Environmental and molecular mutagenesis
|April 5, 2025
概括
这项研究建议在体内突变性测试中使用50%的基准响应 (BMR),使用效果大小理论来确定转基因动物 (TGR) 和Pig-a测试在风险评估中的可靠值.
科学领域:
- 毒理学 毒理学 毒理学
- 基因毒性测试 基因毒性测试
- 风险评估 风险评估
背景情况:
- 基准剂量 (BMD) 方法对于风险评估和监管决策至关重要.
- 定义适当的基因毒性基准反应 (BMR) 值是有争议的.
- 现有的BMR缺乏用于体内突变性检测的标准化.
研究的目的:
- 应用效果大小 (ES) 理论来推导体内转基因动物 (TGR) 和猪-a变异性终点的强大的BMR值.
- 调查实验因素对这些终点的群内变异 (var) 的影响.
- 建议在体内突变性风险评估中使用标准化的BMR.
主要方法:
- 使用Slob (2017) ES理论来定义BMR值.
- 策划了TGR和Pig-a测定剂量反应数据的广泛数据库.
- 进行了BMD分析以确定终点特定的最大值 (c) 和方差 (var).
- 评估了组织,施用途径,持续时间和采样时间对变量的影响.
- 使用同步对照的典型var和修剪SD计算BMR.
主要成果:
- 实验因素对组内变异 (var) 的影响很小.
- 典型的变量值为TGR的0.19和Pig-a的0.29.
- 使用var计算的终点特定的BMR为47% (TGR) 和60% (Pig-a).
- 使用削减SD计算的BMR为33% (TGR) 和58% (Pig-a).
结论:
- 对于体内致变性终点,建议使用一致的BMR值.
- 建议在风险评估中使用50%的BMR来解释突变致病性剂量-反应数据.
- 这种标准化的BMR提高了基因毒性风险评估的一致性和务实性.
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